Agency Information Collection Activities: Submission for OMB Review; Comment Request, 59549-59553 [E9-27641]
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Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
59549
TABLE 5.—COLLECTION OF INFORMATION REQUIRED BY CURRENT REGULATIONS AND STANDARDS—Continued
PHS Guideline
Section
21 CFR Section (unless otherwise stated)
Description of Collection of Information Activity
3.2.4
Procedures consistent for accreditation by the Association for Assessment and
Accreditation of Laboratory Animal Care International (AAALAC International)
and consistent with the National Research Council’s (NRC) Guide
AAALAC International Rules of
Accreditation2 and NRC
Guide3
3.2.5, 3.4, and 3.4.1
Herd health maintenance and surveillance to be documented, available, and in
accordance with documented procedures; record standard veterinary care
211.100 and 211.122
3.2.6
Animal facility SOPs
PHS Policy1
3.3.3
Validate assay methods
211.160(a)
3.6.1
Procurement and processing of xenografts using documented aseptic conditions
211.100 and 211.122
3.6.2
Develop, implement, and enforce SOP’s for procurement and screening processes
211.84(d) and 211.122(c)
3.6.4
Communicate to FDA animal necropsy findings pertinent to health of recipient
312.32(c)
3.7.1
PHS specimens to be linked to health records; provide to FDA justification for
types of tissues, cells, and plasma, and quantities of plasma and leukocytes
collected
312.23(a)(6)
4.1.1
Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program life-long (justify >2 yrs.); investigator case histories (2 yrs.
After investigation is discontinued)
312.23(a)(6)(iii)(f) and
(a)(6)(iii)(g), and 312.62(b)
and (c)
4.1.2
Sponsor to justify amount and type of reserve samples
211.122
4.1.2.2
System for prompt retrieval of PHS specimens and linkage to medical records
(recipient and source animal)
312.57(a)
4.1.2.3
Notify FDA of a clinical episode potentially representing a xenogeneic infection
312.32
4.2.2.1
Document collaborations (transfer of obligation)
312.52
4.2.3.1
Develop educational materials (sponsor provides investigators with information
needed to conduct investigation properly)
312.50
4.3
Sponsor to keep records of receipt, shipment, and disposition of investigative
drug; investigator to keep records of case histories
312.57 and 312.62(b)
1 The ‘‘Public Health Service Policy on Humane Care and Use of Laboratory Animals’’ (https://www.grants.nih.gov/grants/olaw/references/
phspol.htm). (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.)
2 AAALAC International Rules of Accreditation (https://www.aaalac.org/accreditation/rules.cfm). (FDA has verified the Web site address, but is
not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.)
3 The NRC’s ‘‘Guide for the Care and Use of Laboratory Animals’’ (1996).
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27658 Filed 11–17–09; 8:45 am]
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
BILLING CODE 4160–01–S
Project: Recovery Services for
Adolescents and Families—New
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Substance Abuse
Treatment will conduct a data collection
on the helpfulness of recovery support
services for young people and their
families after leaving substance abuse
treatment. Specifically, the Recovery
Services for Adolescents and Families
(RSAF) project is evaluating a pilot test
of the following recovery support
services for young people and their
families find the following recovery
support services helpful: (1) Telephone/
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Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
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text message support; (2) a recoveryoriented social networking site; and (3)
a family program. Approximately 200
adolescent respondents will be asked to
complete 4 data collection forms (some
repeated) during 5 interviews (baseline
and 4 follow-ups) over a 12 month
period after enrollment or discharge
from treatment. Approximately 200
collateral respondents (i.e., a parent/
guardian/concerned other) will be asked
to complete 7 data collection forms
(some repeated) during 5 interviews
(baseline and 4 follow-ups) over a 12
month period after their adolescent’s
enrollment or discharge from treatment.
Approximately 15 to 20 project staff
respondents, including Project
Coordinators, Telephone Support
Volunteers, a Social Network Site
Moderator, Family Program Clinicians,
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and a Support Services Supervisor, will
be asked to complete between 2 and 5
data collection forms at varying
intervals during the delivery of recovery
support services. Across all
respondents, a total of 28 data collection
forms will be used. Depending on the
time interval and task, information
collections will take anywhere from
about 5 minutes to 2 hours to complete.
A description of each data collection
form follows:
Adolescent Participant
• Global Appraisal of Individual
Needs—Initial (GAIN–I 5.6.0 Full). The
GAIN is an evidence-based assessment
used with both adolescents and adults
and in outpatient, intensive outpatient,
partial hospitalization, methadone,
short-term residential, long-term
residential, therapeutic community, and
correctional programs. There are over
1,000 questions in this initial version
that are in multiple formats, including
multiple choice, yes/no, and openended. Eight content areas are covered:
Background, Substance Use, Physical
Health, Risk Behaviors and Disease
Prevention, Mental and Emotional
Health, Environment and Living
Situation, Legal, and Vocational. Each
section contains questions on the
recency of problems, breadth of
symptoms, and recent prevalence as
well as lifetime service utilization,
recency of utilization, and frequency of
recent utilization. GPRA data are
gathered as part of this instrument in
support of performance measurement
for SAMHSA programs. It is
administered at intake into treatment by
clinical staff and used as baseline data
for the project.
• Global Appraisal of Individual
Needs—Monitoring 90 Days (GAIN–M90
5.6.0 Full). The GAIN is an evidencebased assessment used with both
adolescents and adults and in
outpatient, intensive outpatient, partial
hospitalization, methadone, short-term
residential, long-term residential,
therapeutic community, and
correctional programs. There are over
500 questions in this follow-up version
that are in multiple formats, including
multiple choice, yes/no, and openended. Eight content areas are covered:
Background, Substance Use, Physical
Health, Risk Behaviors and Disease
Prevention, Mental and Emotional
Health, Environment and Living
Situation, Legal, and Vocational. Each
section contains questions on the
recency of problems, breadth of
symptoms, and recent prevalence as
well as lifetime service utilization,
recency of utilization, and frequency of
recent utilization. GPRA data are
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gathered as part of this instrument in
support of performance measurement
for SAMHSA programs. It is
administered by project staff at each of
the follow-up timepoints.
• Supplemental Assessment Form
(SAF 0309). The SAF contains 72
questions that are a combination of
multiple choice, yes/no, and openended formats. Content areas include:
race, happiness with parent or caregiver
in several life areas, participation in
prosocial activities, receipt of and
satisfaction with telephone support
services, and usage of and satisfaction
with the project’s social networking site.
It is administered by project staff at each
of the follow-up timepoints.
Collateral Participant (Parent/
Guardian)
• Global Appraisal of Individual
Needs—Collateral Monitoring—Initial
(GCI). The GCI contains over 200 items
in this initial version that are in
multiple formats, including multiple
choice, yes/no, and open-ended. The
following content areas are covered:
relationship to the adolescent
respondent, background, and the
adolescent’s background and substance
use, environment and living situation,
and vocational information. There are
questions on the recency of problems,
breadth of symptoms, and recent
prevalence as well as lifetime service
utilization, recency of utilization, and
frequency of recent utilization. It is
administered at baseline by project staff.
• Global Appraisal of Individual
Needs—Collateral Monitoring—
Monitoring (GCM 5.3.3). The GCM
contains over 200 items in this followup version that are in multiple formats,
including multiple choice, yes/no, and
open-ended. The following content
areas are covered: relationship to the
adolescent respondent, background, and
the adolescent’s background and
substance use, environment and living
situation, and vocational information.
There are questions on the recency of
problems, breadth of symptoms, and
recent prevalence as well as lifetime
service utilization, recency of
utilization, and frequency of recent
utilization. It is administered at each of
the follow-up timepoints by project
staff.
• Supplemental Assessment Form—
Collateral (SAF—Collateral). The SAF
contains 72 questions that are a
combination of multiple choice, yes/no,
and open-ended formats. Content areas
include: knowledge about the
adolescent’s participation in prosocial
activities, receipt of and satisfaction
with telephone support services, and
usage of and satisfaction with the
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project’s social networking site. It is
administered at each of the follow-up
timepoints by project staff.
• Self-Evaluation Questionnaire
(SEQ). The SEQ contains 40 multiple
choice items that ask the collateral
about feelings and symptoms of anxiety.
It is administered at each of the followup timepoints by project staff.
• Family Environment Scale (FES).
The FES contains 18 yes/no items that
measure family cohesion and conflict. It
is administered at each of the follow-up
timepoints by project staff.
• Relationship Happiness Scale
(Caregiver Version). The Relationship
Happiness Scale contains 8 items that
ask the collateral about happiness with
his/her relationship with the adolescent
respondent in various life areas. It is
administered at each of the follow-up
timepoints by project staff.
Project Coordinator
• Eligibility Checklist. The Eligibility
Checklist contains 12 yes/no items that
are used to determine whether or not an
adolescent meets inclusion/exclusion
criteria for the project and is eligible to
be approached for informed consent. It
is completed prior to informed consent
by project staff.
• Telephone Support Volunteer
Notification Form. This form contains a
participant’s name and contact
information. It is completed by project
staff and given to volunteers to notify
them when someone is assigned to
receive telephone support.
• Family Program Notification Form.
This form contains a participant’s name.
It is completed by project staff and given
to clinicians to notify them when
someone is assigned to the family
support group.
• Follow-Up Locator Form—
Participant (FLF–P). The FLF–P
contains over 50 items that are a
combination of yes/no, multiple choice,
and open-ended formats. At the time of
informed consent, data are gathered by
project staff about an adolescent’s
contact information, personal contacts,
criminal justice contacts, school/job
contacts, hang-out information, Internet
contacts, and identifying information in
order to locate and interview that
adolescent over multiple follow-up
intervals.
• Follow-Up Locator Form—
Collateral (FLF–C). The FLF–C contains
over 50 items that are a combination of
yes/no, multiple choice, and openended formats. Data are gathered about
a collateral’s contact information,
personal contacts, and job contacts in
order to locate and interview that
collateral over multiple follow-up
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intervals. It is administered at the time
of informed consent by project staff.
• Follow-Up Contact Log. The
Follow-Up Contact Log is open-ended
and provides space for all data collected
during attempted and completed followup contacts, over the phone and inperson, to be recorded. It is completed
throughout the follow-up time period.
• Volunteer/Staff Survey. The
Volunteer/Staff Survey contains 10
items in fill-in-the-blank, yes/no, and
multiple choice formats. Items ask about
background, demographic information,
and role in the project. It is completed
once by all volunteers and staff at the
start of the project.
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Telephone Support Volunteer
• Telephone Support Case Review
Form. The Telephone Support Case
Review Form contains multiple rows
that allow a volunteer to record 5 pieces
of data about adolescents that they make
phone calls to: initials, treatment
discharge status/date, weeks since
treatment discharge, date of last
telephone session, and number of
completed telephone sessions since
discharge. This allows the volunteer and
supervisor to monitor the progress of
active cases. The form is completed by
the volunteers every week.
• Telephone Support Call Log. The
Telephone Support Call Log is openended and provides space for all data
collected during attempted and
completed support contacts to be
recorded. The form is completed by the
volunteer throughout the period of
telephone support.
• Adolescent Telephone Support
Documentation Form. The Adolescent
Telephone Support Documentation
Form contains 22 items that are asked
of an adolescent during a telephone
support contact by a volunteer. The
form is used to record yes/no and openended responses to questions asking
about substance use and recoveryrelated activities. The volunteers
complete the form every time there is a
telephone support session with an
adolescent.
• Telephone Support Discharge Form.
The Telephone Support Discharge Form
contains 10 fields to record the
following information at the end of an
adolescent’s participation in telephone
support: adolescent name, today’s date,
volunteer name, notification date,
telephone support intake date,
telephone support discharge date,
reason for discharge, number of
completed sessions, referral for more
intervention, and successful contact for
more intervention. This form is
completed by volunteers when
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telephone support ends for each
adolescent.
• Volunteer/Staff Survey (Telephone
Support Volunteer)—See Volunteer/
Staff Survey (Project Coordinator)
above.
Social Network Site Moderator
• Social Networking Moderator Log.
The Social Networking Moderator Log
contains 11 fields for the moderator to
record usage data for the project’s social
networking site. The moderator tracks
number of visits to the site, number of
unique visitors, messages posted, chat
room attendance, and problems with
users. This form is completed weekly by
project staff.
• Volunteer/Staff Survey—See
Volunteer/Staff Survey (Project
Coordinator) above.
Family Program Clinician
• Family Program Progress Notes.
The Family Program Progress Notes
form is open-ended and provides space
for all data collected during attempted
and completed family program contacts
to be recorded. This form is completed
by the clinician throughout the time
family members are active in the family
support program.
• Family Program Attendance Log.
The Family Program Attendance Log is
used to record 6 pieces of information
about each attempted session: Session
number, scheduled date, was the
session rescheduled (yes/no), was the
family member a no-show (yes/no), did
the family member attend the session
(yes/no), and comments. This form is
completed by the clinician throughout
the time family members are active in
the family support program.
• Family Program Case Review
Report. The Family Program Case
Review Report contains multiple rows
that allow a clinician to record
information that allows the clinician
and supervisor to monitor the progress
of active cases. Areas asked about
include: family program procedures
delivered, date of last session, and
weeks in family program. This form is
completed by the clinician weekly
throughout the time family members are
active in the family support program.
• Family Program Discharge Form.
The Family Program Discharge Form
contains 9 fields to record the following
information at the end of participation
in the family program: caregiver name,
today’s date, adolescent name,
notification date, clinician name, family
program intake date, family program
discharge date, reason for discharge, and
number of completed sessions. This
form is completed by the clinician each
time family members of a given
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59551
participant end involvement in the
family support program.
• Volunteer/Staff Survey—See
Volunteer/Staff Survey (Project
Coordinator) above.
Support Services Supervisor
• Adolescent Telephone Support
Quality Assurance Checklist. This
checklist contains 43 items that ask the
supervisor to rate how well a telephone
support volunteer delivered required
service components to adolescents.
Volunteers are rated on a scale of 1
through 5 in the following areas:
substance use since last call (no use),
substance use since last call (use),
substance use since last call (still using),
substance use since last call (stopped
using), attendance at 12-step meetings,
recovery-related activities, activities
related to global health, follow-up since
last call, closing the call, overall, general
clinical skills, and overall difficulty of
session. This form is completed for each
reviewed recording of a telephone
session by a supervisor.
• Social Networking Quality
Assurance Checklist. This checklist
contains 17 items that ask the
supervisor to rate how well a social
networking site moderator delivered
required service components to
adolescents. The moderator is rated on
a scale of 1 through 5 in the following
areas: group discussions, administrative
tasks, overall, and general skills. This
form is completed for each review of the
social networking site by a supervisor.
• Family Program QA Checklist. This
checklist contains 72 items that ask the
supervisor to rate how well a family
program clinician delivered required
service components to family members.
The clinician is rated on a scale of 1
through 5 in the following areas: initial
meeting motivational strategies,
domestic violence precautions,
functional analysis of substance use,
positive communication skills, use of
positive reinforcement, time out from
positive reinforcement, allowing the
identified patient to experience the
natural consequences of substance use,
helping concerned significant others’
enrich their own lives, maintaining the
identified patient in recovery-oriented
systems of care, and general. This form
is completed for each reviewed
recording of a family session by a
supervisor.
• Volunteer/Staff Survey—See
Volunteer/Staff Survey (Project
Coordinator) above.
The following table is a list of the
hour burden of the information
collection by form and by respondent:
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DETAILED INFORMATION ON FORMS GROUPED BY RESPONDENT
Responses
per respondent
Number of
respondents
Instrument/form
Total
responses
Total
annualized hour
burden *
Hours per
response
Adolescent Participant
GAIN–I 5.6.0 Full ...............................................................
200
1
200
2
400
GAIN–M90 5.6.0 Full .........................................................
SAF ....................................................................................
200
200
4
5
800
1,000
1
.25
800
250
Subtotal .......................................................................
200
........................
2,000
........................
1,450
Collateral (Parent/Guardian/Concerned Other) Participant
Collateral-I ..........................................................................
Collateral-M ........................................................................
Collateral SAF ....................................................................
Self-Evaluation Questionnaire ...........................................
Family Environment Scale (Cohesion and Conflict
Scales) ............................................................................
Relationship Happiness Scale (Caregiver) ........................
200
200
200
200
1
4
5
5
200
800
1,000
1,000
.25
.25
.25
.16
50
200
250
250
200
200
5
5
1,000
1,000
.08
.08
80
80
Subtotal .......................................................................
200
........................
5,000
........................
910
Project Coordinator
Eligibility Checklist .............................................................
Locator—Participant ...........................................................
Locator—Collateral ............................................................
Follow-Up Contact Log ......................................................
Telephone Support Volunteer Notification Form ...............
Family Program Notification Form .....................................
Volunteer/Staff Survey .......................................................
4
4
4
4
4
4
4
50
50
50
50
50
50
1
200
200
200
200
200
200
4
.25
.32
.25
.16
.16
.16
.25
50
64
50
32
32
32
1
Subtotal .......................................................................
4
........................
1,204
........................
261
Telephone Support Volunteer
Telephone Support Case Review Form ............................
Telephone Support Call Log ..............................................
Telephone Support Documentation Form .........................
Telephone Support Discharge Form .................................
Volunteer/Staff Survey .......................................................
8
8
8
8
8
450
25
450
25
1
3,600
200
3,600
200
8
.25
.16
.5
.16
.25
900
32
1,800
32
2
Subtotal .......................................................................
8
........................
7,608
........................
2,766
26
Social Network Site Moderator
Social Networking Moderator Log .....................................
Volunteer/Staff Survey .......................................................
1
1
52
1
52
1
.5
.25
Subtotal .......................................................................
1
........................
53
........................
.25
26.25
Family Program Clinician
Family Program Progress Notes .......................................
Family Program Attendance Log .......................................
Family Program Case Review Form .................................
Family Program Discharge Form .......................................
Volunteer/Staff Survey .......................................................
4
4
4
4
4
650
50
650
50
1
2,600
200
2,600
200
4
.16
.08
.25
.16
.25
416
16
650
32
1
Subtotal .......................................................................
4
........................
5,604
........................
1,115
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Support Services Supervisor
Telephone Support QA Checklist ......................................
Social Networking QA Checklist ........................................
Family Program QA Checklist ...........................................
Volunteer/Staff Survey .......................................................
1
1
1
1
12
12
12
1
12
12
12
1
1
.5
1
.25
12
6
12
.25
Subtotal .......................................................................
1
........................
37
........................
30.25
Total .....................................................................
418
........................
21,506
........................
6,558.50
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59553
ANNUALIZED SUMMARY TABLE
Number of
respondents
Respondents
Total
responses
Total
annualized hour
burden *
Adolescent .................................................................................................................................
Collateral ....................................................................................................................................
Project Coordinator ....................................................................................................................
Telephone Support Volunteer ....................................................................................................
Social Network Site Moderator ..................................................................................................
Family Program Clinician ...........................................................................................................
Support Services Supervisor .....................................................................................................
200
200
4
8
1
4
1
2,000
5,000
1,204
7,608
53
5,604
37
1,450
910
261
2,766
26.25
1,115
30.25
Total ....................................................................................................................................
418
21,506
6,558.50
Written comments and
recommendations concerning the
proposed information collection should
be sent by December 18, 2009 to:
SAMHSA Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503; due to potential
delays in OMB’s receipt and processing
of mail sent through the U.S. Postal
Service, respondents are encouraged to
submit comments by fax to: 202–395–
5806.
Dated: November 12, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9–27641 Filed 11–17–09; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0532]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study of Nutrition Facts Label Formats
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
an experimental study of Nutrition Facts
label formats.
* Total Annualized Hour Burden = Total
Responses × Hours per Response.
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DATES: Submit written or electronic
comments on the collection of
information by January 19, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
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validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Experimental Study of Nutrition Facts
Label Formats—(Section 903(d)(2)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)(C))) (OMB
Control Number 0910–NEW)
I. Description
Nutrition information is required on
most packaged foods and this
information must be provided in a
specific format as defined in 21 CFR
101. 9. When FDA was determining
which Nutrition Facts label format to
require, the agency undertook consumer
research to evaluate alternatives (Refs. 1,
2, and 3). More recently, FDA
conducted qualitative consumer
research on the format of the Nutrition
Facts label on behalf of the agency’s
Obesity Working Group (OWG) (Ref. 4),
which was formed in 2003 and tasked
with outlining a plan to help confront
the problem of obesity in the United
States (Ref. 5). In addition to conducting
consumer research, in response to the
OWG plan FDA issued two Advance
Notices of Proposed Rulemaking
(ANPRM) requesting comments on
format changes to the Nutrition Facts
label. One ANPRM requested comments
on whether and, if so, how to give
greater emphasis to calories on the
Nutrition Facts label (Ref. 6) and the
other requested comments on whether
and, if so, how to amend the agency’s
serving size regulations (Ref. 7). In 2007,
FDA issued an ANPRM requesting
comments on whether the agency
should require that certain nutrients be
added or removed from the Nutrition
Facts label (Ref. 8).
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59549-59553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27641]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and Mental Health Services
Administration (SAMHSA) will publish a summary of information
collection requests under OMB review, in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Project: Recovery Services for Adolescents and Families--New
The Substance Abuse and Mental Health Services Administration's
(SAMHSA) Center for Substance Abuse Treatment will conduct a data
collection on the helpfulness of recovery support services for young
people and their families after leaving substance abuse treatment.
Specifically, the Recovery Services for Adolescents and Families (RSAF)
project is evaluating a pilot test of the following recovery support
services for young people and their families find the following
recovery support services helpful: (1) Telephone/text message support;
(2) a recovery-oriented social networking site; and (3) a family
program. Approximately 200 adolescent respondents will be asked to
complete 4 data collection forms (some repeated) during 5 interviews
(baseline and 4 follow-ups) over a 12 month period after enrollment or
discharge from treatment. Approximately 200 collateral respondents
(i.e., a parent/guardian/concerned other) will be asked to complete 7
data collection forms (some repeated) during 5 interviews (baseline and
4 follow-ups) over a 12 month period after their adolescent's
enrollment or discharge from treatment. Approximately 15 to 20 project
staff respondents, including Project Coordinators, Telephone Support
Volunteers, a Social Network Site Moderator, Family Program Clinicians,
[[Page 59550]]
and a Support Services Supervisor, will be asked to complete between 2
and 5 data collection forms at varying intervals during the delivery of
recovery support services. Across all respondents, a total of 28 data
collection forms will be used. Depending on the time interval and task,
information collections will take anywhere from about 5 minutes to 2
hours to complete. A description of each data collection form follows:
Adolescent Participant
Global Appraisal of Individual Needs--Initial (GAIN-I
5.6.0 Full). The GAIN is an evidence-based assessment used with both
adolescents and adults and in outpatient, intensive outpatient, partial
hospitalization, methadone, short-term residential, long-term
residential, therapeutic community, and correctional programs. There
are over 1,000 questions in this initial version that are in multiple
formats, including multiple choice, yes/no, and open-ended. Eight
content areas are covered: Background, Substance Use, Physical Health,
Risk Behaviors and Disease Prevention, Mental and Emotional Health,
Environment and Living Situation, Legal, and Vocational. Each section
contains questions on the recency of problems, breadth of symptoms, and
recent prevalence as well as lifetime service utilization, recency of
utilization, and frequency of recent utilization. GPRA data are
gathered as part of this instrument in support of performance
measurement for SAMHSA programs. It is administered at intake into
treatment by clinical staff and used as baseline data for the project.
Global Appraisal of Individual Needs--Monitoring 90 Days
(GAIN-M90 5.6.0 Full). The GAIN is an evidence-based assessment used
with both adolescents and adults and in outpatient, intensive
outpatient, partial hospitalization, methadone, short-term residential,
long-term residential, therapeutic community, and correctional
programs. There are over 500 questions in this follow-up version that
are in multiple formats, including multiple choice, yes/no, and open-
ended. Eight content areas are covered: Background, Substance Use,
Physical Health, Risk Behaviors and Disease Prevention, Mental and
Emotional Health, Environment and Living Situation, Legal, and
Vocational. Each section contains questions on the recency of problems,
breadth of symptoms, and recent prevalence as well as lifetime service
utilization, recency of utilization, and frequency of recent
utilization. GPRA data are gathered as part of this instrument in
support of performance measurement for SAMHSA programs. It is
administered by project staff at each of the follow-up timepoints.
Supplemental Assessment Form (SAF 0309). The SAF contains
72 questions that are a combination of multiple choice, yes/no, and
open-ended formats. Content areas include: race, happiness with parent
or caregiver in several life areas, participation in prosocial
activities, receipt of and satisfaction with telephone support
services, and usage of and satisfaction with the project's social
networking site. It is administered by project staff at each of the
follow-up timepoints.
Collateral Participant (Parent/Guardian)
Global Appraisal of Individual Needs--Collateral
Monitoring--Initial (GCI). The GCI contains over 200 items in this
initial version that are in multiple formats, including multiple
choice, yes/no, and open-ended. The following content areas are
covered: relationship to the adolescent respondent, background, and the
adolescent's background and substance use, environment and living
situation, and vocational information. There are questions on the
recency of problems, breadth of symptoms, and recent prevalence as well
as lifetime service utilization, recency of utilization, and frequency
of recent utilization. It is administered at baseline by project staff.
Global Appraisal of Individual Needs--Collateral
Monitoring--Monitoring (GCM 5.3.3). The GCM contains over 200 items in
this follow-up version that are in multiple formats, including multiple
choice, yes/no, and open-ended. The following content areas are
covered: relationship to the adolescent respondent, background, and the
adolescent's background and substance use, environment and living
situation, and vocational information. There are questions on the
recency of problems, breadth of symptoms, and recent prevalence as well
as lifetime service utilization, recency of utilization, and frequency
of recent utilization. It is administered at each of the follow-up
timepoints by project staff.
Supplemental Assessment Form--Collateral (SAF--
Collateral). The SAF contains 72 questions that are a combination of
multiple choice, yes/no, and open-ended formats. Content areas include:
knowledge about the adolescent's participation in prosocial activities,
receipt of and satisfaction with telephone support services, and usage
of and satisfaction with the project's social networking site. It is
administered at each of the follow-up timepoints by project staff.
Self-Evaluation Questionnaire (SEQ). The SEQ contains 40
multiple choice items that ask the collateral about feelings and
symptoms of anxiety. It is administered at each of the follow-up
timepoints by project staff.
Family Environment Scale (FES). The FES contains 18 yes/no
items that measure family cohesion and conflict. It is administered at
each of the follow-up timepoints by project staff.
Relationship Happiness Scale (Caregiver Version). The
Relationship Happiness Scale contains 8 items that ask the collateral
about happiness with his/her relationship with the adolescent
respondent in various life areas. It is administered at each of the
follow-up timepoints by project staff.
Project Coordinator
Eligibility Checklist. The Eligibility Checklist contains
12 yes/no items that are used to determine whether or not an adolescent
meets inclusion/exclusion criteria for the project and is eligible to
be approached for informed consent. It is completed prior to informed
consent by project staff.
Telephone Support Volunteer Notification Form. This form
contains a participant's name and contact information. It is completed
by project staff and given to volunteers to notify them when someone is
assigned to receive telephone support.
Family Program Notification Form. This form contains a
participant's name. It is completed by project staff and given to
clinicians to notify them when someone is assigned to the family
support group.
Follow-Up Locator Form--Participant (FLF-P). The FLF-P
contains over 50 items that are a combination of yes/no, multiple
choice, and open-ended formats. At the time of informed consent, data
are gathered by project staff about an adolescent's contact
information, personal contacts, criminal justice contacts, school/job
contacts, hang-out information, Internet contacts, and identifying
information in order to locate and interview that adolescent over
multiple follow-up intervals.
Follow-Up Locator Form--Collateral (FLF-C). The FLF-C
contains over 50 items that are a combination of yes/no, multiple
choice, and open-ended formats. Data are gathered about a collateral's
contact information, personal contacts, and job contacts in order to
locate and interview that collateral over multiple follow-up
[[Page 59551]]
intervals. It is administered at the time of informed consent by
project staff.
Follow-Up Contact Log. The Follow-Up Contact Log is open-
ended and provides space for all data collected during attempted and
completed follow-up contacts, over the phone and in-person, to be
recorded. It is completed throughout the follow-up time period.
Volunteer/Staff Survey. The Volunteer/Staff Survey
contains 10 items in fill-in-the-blank, yes/no, and multiple choice
formats. Items ask about background, demographic information, and role
in the project. It is completed once by all volunteers and staff at the
start of the project.
Telephone Support Volunteer
Telephone Support Case Review Form. The Telephone Support
Case Review Form contains multiple rows that allow a volunteer to
record 5 pieces of data about adolescents that they make phone calls
to: initials, treatment discharge status/date, weeks since treatment
discharge, date of last telephone session, and number of completed
telephone sessions since discharge. This allows the volunteer and
supervisor to monitor the progress of active cases. The form is
completed by the volunteers every week.
Telephone Support Call Log. The Telephone Support Call Log
is open-ended and provides space for all data collected during
attempted and completed support contacts to be recorded. The form is
completed by the volunteer throughout the period of telephone support.
Adolescent Telephone Support Documentation Form. The
Adolescent Telephone Support Documentation Form contains 22 items that
are asked of an adolescent during a telephone support contact by a
volunteer. The form is used to record yes/no and open-ended responses
to questions asking about substance use and recovery-related
activities. The volunteers complete the form every time there is a
telephone support session with an adolescent.
Telephone Support Discharge Form. The Telephone Support
Discharge Form contains 10 fields to record the following information
at the end of an adolescent's participation in telephone support:
adolescent name, today's date, volunteer name, notification date,
telephone support intake date, telephone support discharge date, reason
for discharge, number of completed sessions, referral for more
intervention, and successful contact for more intervention. This form
is completed by volunteers when telephone support ends for each
adolescent.
Volunteer/Staff Survey (Telephone Support Volunteer)--See
Volunteer/Staff Survey (Project Coordinator) above.
Social Network Site Moderator
Social Networking Moderator Log. The Social Networking
Moderator Log contains 11 fields for the moderator to record usage data
for the project's social networking site. The moderator tracks number
of visits to the site, number of unique visitors, messages posted, chat
room attendance, and problems with users. This form is completed weekly
by project staff.
Volunteer/Staff Survey--See Volunteer/Staff Survey
(Project Coordinator) above.
Family Program Clinician
Family Program Progress Notes. The Family Program Progress
Notes form is open-ended and provides space for all data collected
during attempted and completed family program contacts to be recorded.
This form is completed by the clinician throughout the time family
members are active in the family support program.
Family Program Attendance Log. The Family Program
Attendance Log is used to record 6 pieces of information about each
attempted session: Session number, scheduled date, was the session
rescheduled (yes/no), was the family member a no-show (yes/no), did the
family member attend the session (yes/no), and comments. This form is
completed by the clinician throughout the time family members are
active in the family support program.
Family Program Case Review Report. The Family Program Case
Review Report contains multiple rows that allow a clinician to record
information that allows the clinician and supervisor to monitor the
progress of active cases. Areas asked about include: family program
procedures delivered, date of last session, and weeks in family
program. This form is completed by the clinician weekly throughout the
time family members are active in the family support program.
Family Program Discharge Form. The Family Program
Discharge Form contains 9 fields to record the following information at
the end of participation in the family program: caregiver name, today's
date, adolescent name, notification date, clinician name, family
program intake date, family program discharge date, reason for
discharge, and number of completed sessions. This form is completed by
the clinician each time family members of a given participant end
involvement in the family support program.
Volunteer/Staff Survey--See Volunteer/Staff Survey
(Project Coordinator) above.
Support Services Supervisor
Adolescent Telephone Support Quality Assurance Checklist.
This checklist contains 43 items that ask the supervisor to rate how
well a telephone support volunteer delivered required service
components to adolescents. Volunteers are rated on a scale of 1 through
5 in the following areas: substance use since last call (no use),
substance use since last call (use), substance use since last call
(still using), substance use since last call (stopped using),
attendance at 12-step meetings, recovery-related activities, activities
related to global health, follow-up since last call, closing the call,
overall, general clinical skills, and overall difficulty of session.
This form is completed for each reviewed recording of a telephone
session by a supervisor.
Social Networking Quality Assurance Checklist. This
checklist contains 17 items that ask the supervisor to rate how well a
social networking site moderator delivered required service components
to adolescents. The moderator is rated on a scale of 1 through 5 in the
following areas: group discussions, administrative tasks, overall, and
general skills. This form is completed for each review of the social
networking site by a supervisor.
Family Program QA Checklist. This checklist contains 72
items that ask the supervisor to rate how well a family program
clinician delivered required service components to family members. The
clinician is rated on a scale of 1 through 5 in the following areas:
initial meeting motivational strategies, domestic violence precautions,
functional analysis of substance use, positive communication skills,
use of positive reinforcement, time out from positive reinforcement,
allowing the identified patient to experience the natural consequences
of substance use, helping concerned significant others' enrich their
own lives, maintaining the identified patient in recovery-oriented
systems of care, and general. This form is completed for each reviewed
recording of a family session by a supervisor.
Volunteer/Staff Survey--See Volunteer/Staff Survey
(Project Coordinator) above.
The following table is a list of the hour burden of the information
collection by form and by respondent:
[[Page 59552]]
Detailed Information on Forms Grouped by Respondent
----------------------------------------------------------------------------------------------------------------
Total
Instrument/form Number of Responses per Total Hours per annualized
respondents respondent responses response hour burden *
----------------------------------------------------------------------------------------------------------------
Adolescent Participant
----------------------------------------------------------------------------------------------------------------
GAIN-I 5.6.0 Full............... 200 1 200 2 400
----------------------------------------------------------------------------------------------------------------
GAIN-M90 5.6.0 Full............. 200 4 800 1 800
SAF............................. 200 5 1,000 .25 250
-------------------------------------------------------------------------------
Subtotal.................... 200 .............. 2,000 .............. 1,450
----------------------------------------------------------------------------------------------------------------
Collateral (Parent/Guardian/Concerned Other) Participant
----------------------------------------------------------------------------------------------------------------
Collateral-I.................... 200 1 200 .25 50
Collateral-M.................... 200 4 800 .25 200
Collateral SAF.................. 200 5 1,000 .25 250
Self-Evaluation Questionnaire... 200 5 1,000 .16 250
Family Environment Scale 200 5 1,000 .08 80
(Cohesion and Conflict Scales).
Relationship Happiness Scale 200 5 1,000 .08 80
(Caregiver)....................
-------------------------------------------------------------------------------
Subtotal.................... 200 .............. 5,000 .............. 910
----------------------------------------------------------------------------------------------------------------
Project Coordinator
----------------------------------------------------------------------------------------------------------------
Eligibility Checklist........... 4 50 200 .25 50
Locator--Participant............ 4 50 200 .32 64
Locator--Collateral............. 4 50 200 .25 50
Follow-Up Contact Log........... 4 50 200 .16 32
Telephone Support Volunteer 4 50 200 .16 32
Notification Form..............
Family Program Notification Form 4 50 200 .16 32
Volunteer/Staff Survey.......... 4 1 4 .25 1
-------------------------------------------------------------------------------
Subtotal.................... 4 .............. 1,204 .............. 261
----------------------------------------------------------------------------------------------------------------
Telephone Support Volunteer
----------------------------------------------------------------------------------------------------------------
Telephone Support Case Review 8 450 3,600 .25 900
Form...........................
Telephone Support Call Log...... 8 25 200 .16 32
Telephone Support Documentation 8 450 3,600 .5 1,800
Form...........................
Telephone Support Discharge Form 8 25 200 .16 32
Volunteer/Staff Survey.......... 8 1 8 .25 2
-------------------------------------------------------------------------------
Subtotal.................... 8 .............. 7,608 .............. 2,766
----------------------------------------------------------------------------------------------------------------
Social Network Site Moderator
----------------------------------------------------------------------------------------------------------------
Social Networking Moderator Log. 1 52 52 .5 26
Volunteer/Staff Survey.......... 1 1 1 .25 .25
-------------------------------------------------------------------------------
Subtotal.................... 1 .............. 53 .............. 26.25
----------------------------------------------------------------------------------------------------------------
Family Program Clinician
----------------------------------------------------------------------------------------------------------------
Family Program Progress Notes... 4 650 2,600 .16 416
Family Program Attendance Log... 4 50 200 .08 16
Family Program Case Review Form. 4 650 2,600 .25 650
Family Program Discharge Form... 4 50 200 .16 32
Volunteer/Staff Survey.......... 4 1 4 .25 1
-------------------------------------------------------------------------------
Subtotal.................... 4 .............. 5,604 .............. 1,115
----------------------------------------------------------------------------------------------------------------
Support Services Supervisor
----------------------------------------------------------------------------------------------------------------
Telephone Support QA Checklist.. 1 12 12 1 12
Social Networking QA Checklist.. 1 12 12 .5 6
Family Program QA Checklist..... 1 12 12 1 12
Volunteer/Staff Survey.......... 1 1 1 .25 .25
-------------------------------------------------------------------------------
Subtotal.................... 1 .............. 37 .............. 30.25
-------------------------------------------------------------------------------
Total................... 418 .............. 21,506 .............. 6,558.50
----------------------------------------------------------------------------------------------------------------
[[Page 59553]]
Annualized Summary Table
----------------------------------------------------------------------------------------------------------------
Total
Respondents Number of Total annualized
respondents responses hour burden *
----------------------------------------------------------------------------------------------------------------
Adolescent...................................................... 200 2,000 1,450
Collateral...................................................... 200 5,000 910
Project Coordinator............................................. 4 1,204 261
Telephone Support Volunteer..................................... 8 7,608 2,766
Social Network Site Moderator................................... 1 53 26.25
Family Program Clinician........................................ 4 5,604 1,115
Support Services Supervisor..................................... 1 37 30.25
-----------------------------------------------
Total....................................................... 418 21,506 6,558.50
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent by December 18, 2009 to: SAMHSA
Desk Officer, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, DC
20503; due to potential delays in OMB's receipt and processing of mail
sent through the U.S. Postal Service, respondents are encouraged to
submit comments by fax to: 202-395-5806.
---------------------------------------------------------------------------
* Total Annualized Hour Burden = Total Responses x Hours per
Response.
Dated: November 12, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-27641 Filed 11-17-09; 8:45 am]
BILLING CODE 4162-20-P
